This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm.

Drug: SKL11197

SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.

Placebo Comparator: Placebo

This arm is the placebo comparator arm. Patients will be randomized to this arm.

Drug: Placebo

This is the placebo. Patients will be randomized the placebo.

Detailed Description:

This study is a double-blind, placebo controlled study with three phases;

a pre-study medication washout/screening phase upto 3 weeks

a 3-week, open label phase

a 6-week double-blind phase At the end of 3-week in the open label phase, subjects may enter the double-blind phase if they meet the eligibility criteria.

Eligible subjects will be randomized in a blinded fashion either to continue with SKL11197 at 300 mg TID or to take the same number of placebo capsules.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

18 years or older

Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year

At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic);

HbA1c < 12 % at Screening

Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.

Pain from diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and be bilateral.

Females must be of non-childbearing potential (defined as either surgically sterile or at least one year postmenopausal, Menopause is defined as 1 year since last menstrual period with associated subjective sensations), or,

If capable of bearing children, females must use a double-barrier method of contraception, or an intrauterine device. Females capable of bearing children must have negative serum pregnancy (beta-HCG) test at Screening and negative urine pregnancy on Day 1.

Subjects with known clinically significant decreased blood flow to the extremities

Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain

Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure;

Have profound autonomic dysfunction, or brittle diabetes;

Evidence of amputations (including toes), open ulcers, or Charcot joint.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521598